Tympanostomy tube and insertion device

ABSTRACT

A tympanostomy tube applicator has a hand-held housing and a stem extending from the housing and having a shape arranged for engagement in the ear canal. A tympanostomy tube inserter has a user actuator, a rod having a tip to pierce a patient&#39;s tympanic membrane and to support a tympanostomy tube through the membrane where it is pierced. The inserter inserts a collapsed tympanostomy tube through the membrane and expands the tube in situ to provide a distal flange in the tympanostomy tube. A myrongotomy tip expands the tube to a final state having a distal flange as it is retracted.

FIELD OF THE INVENTION

The invention relates to insertion of a tympanostomy tube (“grommet”)into the tympanic membrane.

PRIOR ART DISCUSSION

A tympanostomy tube (also known as a tube) is a small tube inserted intothe tympanic membrane in order to ventilate the middle ear for aprolonged period of time, and to prevent the accumulation of fluid inthe middle ear. The tube is usually inserted under general aesthetic ina surgical environment. The surgeon will use various tools to firstlyclean the outer ear canal, will then use a myringotomy knife to make anincision in the tympanic membrane, and will then use a suction tip toremove fluid from the middle ear. Finally, the surgeon will use acombination of forceps and probe to insert the tympanostomy tube.

U.S.2009/0209972 (Loushin) describes an insertion device which deformsthe ends of a ventilation device to a flange-like structure. It does soby use of a bumper or stop on a cutting member. The bumper or stop maybe inflatable.

U.S.200910099573 (Gonzales) describes a device for inserting atympanostomy tube.

The invention is directed towards achieving a simpler procedure.

SUMMARY OF THE INVENTION

According to the invention, there is provided a tympanostomy tubeapplicator comprising:

-   -   a hand-held housing,    -   a stem extending from the housing and having a shape arranged        for engagement in the ear    -   canal; and    -   a tympanostomy tube inserter;    -   wherein the housing includes at least oats user actuator for        operation of the inserter,    -   wherein the inserter comprises a rod having a tip to pierce a        patient's tympanic membrane and to support a collapsed        tympanostomy tube through the membrane where it is pierced; and    -   wherein the inserter is adapted to expand from within a distal        end of the collapsed tympanostomy tube to provide in situ a        distal flange in the tympanostomy tube,

By pressing the tube from within at the distal end at least, theapplicator can reliably re-configure the tube in situ so that thedesired shape is formed to enable the tube remain in place for thedesired time duration post-surgery. Such a tube expansion action is morerepeatable and effective than the prior art axial pressing approach.

In one embodiment, the inserter comprises a non-inflatable featureadapted to be pulled through the collapsed tube to expand the tube. Inone embodiment, said feature has a curved surface for engagement withthe tube to expand it as the feature is pulled through.

In one embodiment, said surface is on a proximal side of the feature andis curved and narrows towards the proximal direction.

In one embodiment, the inserter comprises a shoulder to act as aproximal stop for the tympanostomy tube during expansion of thetympanostomy tube.

In one embodiment, the collapsed tube comprises distal guide membershaving outer surfaces with a radial inward component to assist guidingof the tube through a patient's tympanic membrane. Preferably, the guidemembers are configured to form part of the distal flange afterinsertion. In one embodiment, the collapsed tube comprises slots orslits between said guide members as reliefs to assist expansion.

In another embodiment, the applicator comprises a handle with theactuator and a cartridge with the stein, the cartridge being releasablyconnected to the handle. In one embodiment, the cartridge includes adistal part of the inserter which is adapted to connect with a proximalpart of the inserter within the handle when the cartridge is connectedto the handle.

Preferably, the inserter comprises a non-inflatable feature adapted tobe pulled through the collapsed tube to expand the tube, the insertercomprises a spring mechanism to pull the feature through the tube, thecartridge is adapted to load the spring mechanism as it is connected tothe handle, and the actuator is adapted to release the spring mechanismto pull the feature.

In one embodiment, the cartridge is adapted to be connected to thehandle in a rotational and translational action, said action causing thespring mechanism to load.

In one embodiment, a plug in the handle or the cartridge engages in asocket in the other of the handle or the cartridge, and inter-engagingfeatures cause a spring of the spring mechanism to be loaded as thecartridge is connected to the handle.

In a further embodiment, the actuator comprises a single buttonprotruding from the housing. In one embodiment, the cartridge ispre-loaded with the tube and the tube is non-removable except byoperation of the inserter.

In one embodiment, the inserter comprises a balloon and means to inflatethe balloon to expand the collapsed tube. Preferably, the balloon islocated proximally of the piercing tip.

In one embodiment, the stem is in the form of a speculum and includes achannel for an endoscope arranged alongside the inserter. In oneembodiment, the housing has an endoscope guide along a side of thehousing. In one embodiment, the applicator further comprises a jig forcalibration of focal point of the endoscope to a known distance beforeinsertion. In one embodiment, the jig comprises a flange for engagementwith the head and a flange for providing a visible plane at a knownfocusing distance.

In one embodiment, the applicator further comprises a guide collar forthe head, said guide collar being configured to engage the patient's earproximally of the ear canal. In one embodiment, the applicator furthercomprises an adjustment mechanism for adjusting longitudinal position ofthe guide collar with respect to the head.

In another aspect, the invention provides a tympanostomy tube comprisinga proximal flange and a shank configured to expand with application offorce from within to form in situ a distal flange and a central ductportion.

In one embodiment, the shank forms an initial distal flange and saidinitial distal flange has slits or slots to facilitate expansion.

In one embodiment, the original distal flange is configured to expand inthe radial dimension to an extent of 20% to 60%.

In one embodiment, the shank is tapered at a distal end with a curvedexternal surface narrowing in the distal direction. Preferably, thetapered distal end comprises circumferentially spaced-apart guidemembers. In one embodiment, the tube comprises a preliminary distalflange and said guide members extend from said preliminary distalflange.

In one embodiment, the tube is of a material having a plastic region ina stress vs. strain curve so that force applied causes it to becomeplastic and permanently deform with expansion of the distal end of theshank to an extent in the range of 20% to 60%.

DETAILED DESCRIPTION OF THE INVENTION BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription of some embodiments thereof, given by way of example onlywith reference to the accompanying drawings in which:

FIG. 1 is a perspective view from above of an insertion device orapplicator of the invention with handle and stem parts separated, andFIGS. 2 and 3 are perspective views when these parts are connected;

FIGS. 4 to 7 are cross-sectional views of the handle part, the sternpart, the stein tip, and the full device respectively;

FIGS. 8( a) to 8(t) are a series of diagrams illustrating deformation ofa tympanostomy tube during insertion;

FIG. 9 is a plot showing tube material deformation characteristics;

FIGS. 10 and 11 are perspective views of a tympanostomy tube applicatorof the invention in another embodiment;

FIG. 12 is a side view of the applicator;

FIG. 13 is a side view showing calibration of the device, and FIG. 14shows it in use; and

FIGS. 15, 16, and 17 are enlarged side views of the head of theapplicator in use deploying a tube.

DESCRIPTION OF THE EMBODIMENTS

Referring to FIGS. 1 to 9 a tympanostomy tube (sometimes referred to asa “grommet”) applicator or insertion device 1 comprises a handle 2 and acartridge 3. The handle 2 has a housing 5 shaped for ergonomic gripping,and a press-button 10 for operation. Also there is a socket 11 toreceive a plug 12 of the cartridge 3. The cartridge 3 has a housing 13which is bent to one side at its distal end, where it supports a stem 14terminating in a tip 15. The stem 14 of the cartridge 3 is flexibleenough to deform to the desired shape during insertion, yet is resistantto compression. It includes a steel helical spring (FIG. 6, 14(a) withinthe stem 14 to allow flexure but good compression strength.

The cartridge is pre-assembled with a tympanostomy tube 60, and so isfor single use on one ear. Its connection to the handle 2 is a twistingand pushing action which has the dual purpose of connecting thecartridge 3 to the handle 2 and also compressing a spring, release ofwhich will subsequently provide the force for tube 60 deformation insitu. The tube has a diameter of 2.5 mm as is typical for a tube of thetype known as the “Shepard” type of tympanostomy tube. When the tube 60has been inserted in one ear, the empty cartridge is removed and asecond (loaded) cartridge is connected to the handle for the second earif required (as is often the case). When this tube has been insertedinto the second ear the handle 2 is disposed of. However, the handle 2may be used if desired with additional loaded cartridges, for examplefor a further patient or upon premature activation of the trigger 10.

The handle 2 is made up of two ergonomic case moulded plastics halves5(a) and 5(h). The cartridge 3 is also made from components 13(a) and13(b) which snap fit together during assembly. The cartridge plug 12 hasa tab 12(a) which mates with a slot 11(a) in the socket 11. Once thecartridge plug 12 is fully inserted into the handle socket 11 thecartridge 3 is rotated to lock it into place. On further rotation of thecartridge 3, the tab 12(a) locks into different mating parts of the slot11(a), which provides the user with different variations of devicesetup. FIG. 3 shows the cartridge 3 set at 90° to the handle 2.

FIG. 4 shows a sectioned view of the handle 2 in a resting configurationprior to connection of the cartridge 3. The handle button 10 hasratchets 30 and 31 which are attached to a rotating drum 32. A part 34of the drum 32 houses a return spring 35 to provide upward bias to thebutton 10. The ratchets 30 and 31 mate with a slider 40 which hasopposing ratchet teeth 41 and 42. A compression component 45 is matedcoaxially to the slider 40 and both are assembled within a compressionspring 46. A rubber ring 50 is housed within the compression component45 to provide damping during use, and there is a complementary dampersleeve 50(a) at the opposite (right side as viewed in FIG. 4) end of theslider 40. As shown by this drawing the slider 40 is in two parts furmanufacturing purposes, however, it may alternatively be moulded as anintegral component. There is a return spring 49 for the slider 40.

Referring to FIGS. 5 and 6, the cartridge 3 has a myringotomy knife 50the distal end of which has a sharp tip 52 for cutting through thetympanic membrane. Behind the tip 52 there is a surface 53 which iscurved and narrows towards the proximal side, for use in deforming thetube 60 as described in more detail below. Immediately proximal to themyringotomy knife tip 52 there is a tympanostomy tube 60 in a collapsedstate. The myringotomy knife 50 has a contoured surface 53 which isconfigured to deform the tympanostomy tube 60 during deployment byexpanding it from within. The myringotomy knife 50 is connected to apuller component 51 via a flexible shaft 56 which trains through thestem 14. A bent feature 55 at the proximal end ensures that it stays incontact with the pull component 51 throughout deployment. The pullcomponent 51 connects with the slider component 40 within the handle 2when the cartridge 3 is connected to the handle 2.

The distal end of the stem 14 has a lip 57 fitting laterally against andextending around almost the full circumference of the side of a tube 60.In addition to helping to secure the tube 60 this also widens the stemend so that it acts as a stop to prevent unintentional excessiveinsertion, and also assists with location of the knife tip 52.

As shown most clearly in FIGS. 8( a) to 8(f) the tube 60 has a proximal(or “outer”) pre-formed flange 61, a central ventilation duct 62, and adistal (or “inner”) flange 63 with slots 64. The flange 63 has adiameter which is smaller than that of the proximal flange 61 by about30% to 40%. There are also lead-in guide members 65 in the form offingers extending generally axially from the distal flange 63. There isone slot 64 between each guide member 65. The slots 64 are grooves whichdo not penetrate for the full depth of the wall of the tube 60. Ingeneral their depth is in the range of about 20% to 90% of the walldepth, and preferably about 80%.

As is clear from FIG. 8 the tube 60 as provided in the cartridge 3already has a distal flange (63), however as noted above this has adiameter less than that of the proximal flange 61. However, the distalflange 63 does not present a problem for insertion through the TMbecause of the action of the guide members 65. The latter have externalsurfaces which are tapered with a radial component which is inward andso allow streamlined insertion through the cut which has been made bythe knife tip 52.

In use, as described above the surgeon connects the cartridge 3 to thehandle by engaging the plug 12 in the socket 11 and rotating and pushingthe cartridge 3 so that it is fully engaged and at the same timecompresses the spring 46 so that it is loaded. The surgeon then movesthe stem 14 through the ear canal and punctures the tympanic membraneusing the myringotomy knife tip 52. Continued movement pushes throughuntil the inner flange 63 and the outer flange 61 are on opposite sidesof the tympanic membrane. The lip 57 helps to prevent the surgeon frompushing the stem 14 too far into the middle ear; this feature acting asa backstop. To deform the tympanostomy tube 60, the surgeon merelypresses the handle button 10. This causes the mechanical advantagewithin the handle 2 to pull on the slider component 51. This in turnpulls the distal lip 52 of the myringotomy knife 50 through thetympanostomy tube 60, causing the tympanostomy tube 60 to deform andrelease from the device 1. This movement is shown in FIGS. 8( a) to8(f).

FIG. 7 shows the cartridge 3 assembled into the handle 2 and the device1 in the primed configuration prior to tube 60 deployment. When thecartridge plug 12 is pushed into the handle socket 11 this pushes on thecompression component 45 which in turn compresses the spring 46.

The user then locks the cartridge 3 into the handle 2 by rotating thecartridge 3, causing the tab 12(a) to lock into place. When the userpushes the button 10 this rotates the button drum 32 which also pushesagainst the spring 35. This disengages the drum ratchets 30 and 31 fromthe slider ratchet 41 and 42 and thereby releases the slider 40 to moveunder the force of the compression spring 46 which in turn actuates thecartridge slider component 51 which is connected to the myringotomyknife 50. The myringotomy knife tip 52 deforms the tympanostomy tube 60and releases it from the cartridge 3. The speed at which the myringotomyknife tip 52 retracts through the tympanostomy tube 60 can be tuned byvarying the stiffness of the compression spring 46.

To reset the system to the resting configuration the user rotates thecartridge 3 from its locked position within the handle 2 and removes thecartridge 3. This releases the compression component 45 and the returnspring 49 resets all components to the initial position shown in FIG. 4.

In more detail, FIG. 8 shows five steps of the myringotomy knife tip 52deforming the tympanostomy tube 60, after it has been located with theassistance of the guides 65. As the proximal surface 53 of themyringotomy knife tip 52 contacts the tympanostomy tube 60, thesurface's angle and slight concave shape causes the tympanostomy tube 60to both expand radially and compress axially. The tympanostomy tube 60relief slots 64 on the inner flange 63 allow the tympanostomy tube 60 todeform to the correct shape. The inner flange 63 only increases indiameter by about 20% to 60%, and preferably in the range of 25% to 40%,however this is sufficient for adequate placement of the tube 60. Itwill be appreciated that the action of pulling through the tip onlyneeds to achieve a limited, gradual and therefore predictabledeformation of the tube 60. The tube's distal (inner) end only needs toturn through about 40° to reach the point of having the same diameter asthe proximal flange.

The mechanical stress strain characteristics of the material used in thetympanostomy tube 60 is advantageous to its correct function anddeployment. The ideal material has a low elongation at the materialyield point relative to its total elongation during plastic deformation.The plastic region of the stress strain curve would be at a minimum 50times the elastic region of the stress strain curve with respect tomaterial elongation. This relationship is shown in FIG. 9.

The tube 60 is suitable for the surgical application of temporarilyventilating the car for a period of about 9 months, and the general typeis typically referred to as the “Shepard” type. However, thetympanostomy tube may in other embodiments be of a different shape suchas those known widely as the “Paperella” tube, or alternatively as the“Reuter Bobbin” tube. Where the shape is for a permanent insertion thetype known as the “T-Tube” may be used. These know shapes are the finaloutline shapes after deformation.

It will be appreciated from FIG. 8 that, in addition to the distalflange 63 expanding to its permanent shape, the guide members 65 changegradually from an orientation with an inward radial component (FIG. 8(a)) to having an outward radial component (FIGS. 8( b) and 8(c)), andthen back again to the inward direction (FIGS. 8( d) to 8(f)). The guidemembers 65 hence play a role during tube 60 expansion, namely helping toretain the correct tube position by exaggerating the inner flangetemporarily as the tip 52 is retracted. It is envisaged that in otherembodiments, the guide members 65 will be configured to be splayed outafter tube deformation, thereby permanently enlarging the distal flange.

It will also be appreciated that the device 1 makes the surgical task oftube insertion simpler, with less room for error. The spring forretraction is automatically loaded by the single action of twisting thecartridge onto the handle, and so this can not be inadvertently omitted.Also, the device 1 more importantly allows the surgeon to locateaccurately the tube and deform it in situ with little risk of movementduring deformation because the only action required is pressing thebutton 10 to release the pre-loaded spring for retraction.

Referring to FIGS. 10 to 17 a tube applicator 100 comprises a housing102 arranged for single-handed grip, and a stem or head 103 with a guidecollar 104. The head is arranged for bead rotation about an axis throughthe housing 102. A guide collar 104 surrounds the head 103. There aretriggers 110 and 111 and a guide collar adjustment button 112. Anendoscope 130 can be trained through a holder 131 and terminate in alens 120 in the head 103, as shown in FIGS. 12 to 14.

The head 103 further comprises an insertion assembly 200 having asleeve-shaped stem 201, a shoulder 202. A rod (not shown) extendsthrough the stem 201 and terminates in an inverted pyramid-shaped tip122. The tip 122 has an upper face on which there is a balloon 204 and atube 203 in a collapsed configuration.

The head 103 at the distal end of the device is indexable with rotationabout an axis extending through the housing 102, with an allowed 180°rotation so that it may be used by either left or right-handed users. Ithas a cylindrical body portion, which can enter the patient's ear canal.The guide collar 4 can adjust the distance between the tip of thecylindrical body and the tympanic membrane.

There is a channel within the device to accept a standard endoscope 130.This is formed by the endoscope guide 131 and the head 103. Theendoscope 130 is pushed through the channel by the user until its lens120 arrives at the tip of the head 103. FIG. 12 shows a detailed view ofthe head cylindrical body, it shows the distal end 120 of the endoscope130 and the pyramid-shaped myringotomy blade tip 122 which is housedwithin the head 103.

Prior to operation of the device, the endoscope is calibrated andfocused using a focus calibration jig 150, shown in FIG. 13. The jig 150comprises a top flange 151 connected to a bottom flange 151 by a web153. Calibration is done by placing the tip of the head 103 in a hole inthe top flange 151 of the jig 150. The endoscope is manipulated andfocused until a target provided by the top surface of the lower flange152 is in sharp focus on the video screen of the endoscope 130. Thisstep is to ensure that the focal length of the endoscope 130 is at afixed distance ‘X’ from the tip of the cylindrical body.

In use, the trigger 111 is operated to cause the insertion assembly 200to extend from the head 103. The collapsed tube 203 comprises a proximalflange 203(a), and a shank 203(b) with slits 203(d).

The clinician's index and middle fingers are placed on both of thetriggers 110 and 111. Her thumb is placed on the button 112, and thering and small fingers are free to rest on the patient's face to detectany movement during the procedure. The patient is typically a child.

As shown in FIG. 14, the device is placed into a patient's ear. Theclinician will adjust the guide collar 104 by pressing the button 112.This will alter the distance between the tip of the head 103 and thetympanic membrane. Once the tympanic membrane is in sharp focus thedistance between the tip of the head 103 and the tympanic membrane is ata constant distance ‘X’. Once the clinician locates the anteriorinferior quadrant of the tympanic membrane they will actuate the trigger111 to extend the tube insertion assembly 200, shown in FIG. 15, fromits sheathed position within the head 103. The tube insertion assembly200 will penetrate the tympanic membrane through the cutting action ofthe myringotomy tip 122 until part of the collapsed tube 203 extendsthrough the membrane. The proximal flange 203(a) of the tube 203 willhelp to prevent penetration too far into the middle ear. Then, actuationof the trigger 110, as shown in FIG. 16, will expand the balloon 204which is under the tube 203. This balloon inflation, will convert thetube shank 203(b) into a distal flange 203(c). This is because the shank203(b) is of a material which defaults easily. In other embodiments thecentre channel of the tube is also formed to its final state during theprocedure. The action of balloon expansion is similar to that ofretracting the knife tip 52 in the device 1, force is applied fromwithin to expand the tube to provide the final shape with two flanges,one on each side of the TM. This radial expansion is a reliable andconsistent way of deforming the original, collapsed, tube. We believethat it is much more effective than the prior approach of axiallyclamping the tube between stops.

The clinician now releases the trigger 110 to deflate the balloon, andreleases the trigger 111 to retract the deflated balloon 204 and the tip122 through the formed tube 203, as shown in FIG. 17. On retraction therod, which terminates in an inverted pyramid-shaped tip 122 and holdsthe balloon 204, will initially retract into the shaft 201. This willaid in ejection of the tube 203 by pushing it against the shoulder 202.Further release of the trigger 111 causes the tube inserter assembly 200to return into the cylindrical body. The head 103 is then removed fromthe patient's ear canal.

The action of the balloon is very effective at expanding the tube fromwithin, as it is for other medical technologies such as stentdeployment. On the other hand, in the embodiment of FIGS. 1 to 9 therole of the expansion balloon of expanding the tube from within isperformed by a non-inflatable feature which is pulled through thecollapsed tube using the trigger. This expands the tube to its final,unstressed, state. Once the curved feature has been pulled through thetube, it releases from the tube and the tube remains in the patient'stympanic membrane. The feature may be of a different shape such asspherical, and its shape may not be curved in side view, for exampleconical.

The tympanostomy tube may be made from a metal such as stainless steelor titanium, any of a range of biocompatible plastics such asfluoropolymers (PTFE, PFA, or ETFE), FEP Silicon, HDPE, or a shapememory plastic/metal such as PEEK/Nitinol. The tympanostomy tube in itscollapsed state has features present in order to aid in the deploymentof the tube. The tympanostomy tube could also have a conical profile(item 300, conical shank 301 as shown in FIG. 18) along its axis so thatwhen the initial myringotomy is made, further actuation of the tubeinserter assembly would dilate the myringotomy in the membrane. Also,the device 1 may have a speculum and endoscope arrangement, and the jig150 may also be used.

The invention is not limited to the embodiments described but may bevaried in construction and detail. For example, the tympanostomy tubemay be of any other known overall outline shape, as set out above. Also,the spring mechanism in the handle may have a spring with is extended toload it rather than being compressed.

1-30. (canceled)
 31. A tympanostomy tube applicator comprising: ahand-held housing; a stem extending from the housing and having a shapearranged for engagement in the ear canal; and a tympanostomy tubeinserter; wherein the housing includes at least one user actuator foroperation of the inserter; wherein the inserter comprises a rod having atip to pierce a patient's tympanic membrane and to support a collapsedtympanostomy tube through the membrane where it is pierced; and whereinthe inserter is configured to expand from within a distal end of acollapsed tympanostomy tube to provide in situ a distal flange in thetympanostomy tube.
 32. The tympanostomy tube applicator as claimed inclaim 31, wherein the inserter comprises a non-inflatable featureconfigured to be pulled through the collapsed tube to expand the tube.33. The tympanostomy tube applicator as claimed in claim 31, wherein theinserter comprises a non-inflatable feature configured to be pulledthrough a collapsed tube to expand the tube; and wherein said featurehas a curved surface for engagement with a tube to expand it as thefeature is pulled through.
 34. The tympanostomy tube applicator asclaimed in claim 31, wherein the inserter comprises a non-inflatablefeature configured to be pulled through a collapsed tube to expand thetube; and wherein said feature has a curved surface for engagement witha tube to expand it as the feature is pulled through; and wherein saidsurface is on a proximal side of the feature and is curved and narrowstowards the proximal direction.
 35. The tympanostomy tube applicator asclaimed in claim 31, wherein the inserter comprises a shoulder to act asa proximal stop for a tympanostomy tube during expansion of atympanostomy tube.
 36. The tympanostomy tube applicator as claimed inclaim 31, further comprising a collapsed tympanostomy tube; and whereinsaid collapsed tube comprises distal guide members having outer surfaceswith a radial inward component to assist guiding of the tube through apatient's tympanic membrane.
 37. The tympanostomy tube applicator asclaimed in claim 31, further comprising a collapsed tympanostomy tube;and wherein the collapsed tube comprises distal guide members havingouter surfaces with a radial inward component to assist guiding of thetube through a patient's tympanic membrane; and wherein the guidemembers are configured to form part of the distal flange afterinsertion.
 38. The tympanostomy tube applicator as claimed in claim 31,further comprising a collapsed tympanostomy tube; and wherein thecollapsed tube comprises slots or slits between said guide members asreliefs to assist expansion.
 39. The tympanostomy tube applicator asclaimed in claim 31, wherein the applicator comprises a handle for theactuator and a cartridge linked with the stem, the cartridge beingreleasably connected to the handle; and wherein the cartridge includes adistal part of the inserter which is configured to connect with aproximal part of the inserter within the handle when the cartridge isconnected to the handle.
 40. The tympanostomy tube applicator as claimedin claim 31, wherein the applicator comprises a handle linked with theactuator and a cartridge linked with the stem, the cartridge beingreleasably connected to the handle; and wherein the cartridge includes adistal part of the inserter which is configured to connect with aproximal part of the inserter within the handle when the cartridge isconnected to the handle; and wherein the inserter comprises anon-inflatable feature configured to be pulled through the collapsedtube to expand the tube, the inserter comprises a spring mechanism topull the feature through the tube, the cartridge is configured to loadthe spring mechanism as it is connected to the handle, and the actuatoris configured to release the spring mechanism to pull the feature. 41.The tympanostomy tube applicator as claimed in claim 31, wherein theapplicator comprises a handle for the actuator and a cartridge linkedwith the stem, the cartridge being releasably connected to the handle;and wherein the cartridge includes a distal part of the inserter whichis configured to connect with a proximal part of the inserter within thehandle when the cartridge is connected to the handle; and wherein theinserter comprises a non-inflatable feature configured to be pulledthrough the collapsed tube to expand the tube, the inserter comprises aspring mechanism to pull the feature through the tube, the cartridge isconfigured to load the spring mechanism as it is connected to thehandle, and the actuator is configured to release the spring mechanismto pull the feature; and wherein the cartridge is configured to beconnected to the handle in a rotational and translational action, saidaction causing the spring mechanism to load.
 42. The tympanostomy tubeapplicator as claimed in claim 31, wherein the applicator comprises ahandle for the actuator and a cartridge linked with the stem, thecartridge being releasably connected to the handle; and wherein thecartridge includes a distal part of the inserter which is configured toconnect with a proximal part of the inserter within the handle when thecartridge is connected to the handle; and wherein the inserter comprisesa non-inflatable feature configured to be pulled through the collapsedtube to expand the tube, the inserter comprises a spring mechanism topull the feature through the tube, the cartridge is configured to loadthe spring mechanism as it is connected to the handle, and the actuatoris configured to release the spring mechanism to pull the feature; andwherein the cartridge is configured to be connected to the handle in arotational and translational action, said action causing the springmechanism to load; and wherein a plug in the handle or the cartridgeengages in a socket in the other of the handle or the cartridge, andinter-engaging features cause a spring of the spring mechanism to beloaded as the cartridge is connected to the handle.
 43. The tympanostomytube applicator as claimed in claim 31, wherein the actuator comprises abutton protruding from the housing; and wherein the cartridge ispre-loaded with a tube and the tube is non-removable except by operationof the inserter.
 44. The tympanostomy tube applicator as claimed inclaim 31, wherein the inserter comprises a balloon and means to inflatethe balloon to expand a collapsed tube.
 45. The tympanostomy tubeapplicator as claimed in claim 31, wherein the inserter comprises aballoon and means to inflate the balloon to expand a collapsed tube; andwherein the balloon is located proximally of the piercing tip.
 46. Thetympanostomy tube applicator as claimed in claim 31, wherein the stem isin the form of a speculum and includes a channel for an endoscopearranged alongside the inserter; and wherein the housing has anendoscope guide along a side of the housing; and wherein the applicatorfurther comprises a jig for calibration of focal point of the endoscopeto a known distance before insertion; wherein the jig comprises a flangefor engagement with the head and a flange for providing a visible planeat a known focusing distance.
 47. The tympanostomy tube applicator asclaimed in claim 31, wherein the applicator further comprises a guidecollar for the head, said guide collar being configured to engage thepatient's ear proximally of the ear canal; and wherein the applicatorfurther comprises an adjustment mechanism for adjusting longitudinalposition of the guide collar with respect to the head.
 48. Atympanostomy tube comprising a proximal flange, and a shank comprisingan initial distal flange configured to expand with application of forcefrom within to form in situ a distal flange and a central duct portion.49. The tympanostomy tube as claimed in claim 48, wherein said initialdistal flange has slits or slots to facilitate expansion; and whereinthe initial distal flange is configured to expand in the radialdimension to an extent of 20% to 60%; and wherein the initial distalflange is tapered at a distal end with a curved external surfacenarrowing in the distal direction.
 50. The tympanostomy tube as claimedin claim 48, wherein the initial distal flange is tapered at a distalend with a curved external surface narrowing in the distal direction;and wherein the tapered distal end comprises circumferentiallyspaced-apart guide members.
 51. The tympanostomy tube as claimed inclaim 48, wherein the tube is of a material having a plastic region in astress vs strain curve so that force applied causes it to become plasticand permanently deform with expansion of the distal end of the shank toan extent in the range of 20% to 60%.